WHO urged to break from pharma in counterfeits battle

The World Health Organisation (WHO) has been urged to scrap an anti-counterfeiting task force which, critics claim, is being unduly influenced by pharmaceutical companies.

Drugmakers’ membership of the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) has created “confusion” over the definition of counterfeit drugs, delegations from Brazil and India told the World Health Assembly (WHA) in Geneva last week. Trade and commercial interests are being disguised as public health issues, influenced by those who would seek to undermine legitimate generic competition, it was claimed, in statements which received widespread support from developing-nation delegates.

IMPACT, which was established in 2006, functions outside the purview of WHO member states. It therefore has no mandate from them nor it is accountable to them, the Assembly heard. In Kenya, advice from IMPACT had provided the basis for the country’s controversial anti-counterfeiting law, the panel having approached the Ministry of Trade on the issue, and the law was passed without any consultation with the Ministry of Health, said the Kenyan delegation, which called for the “marriage” between WHO and IMPACT to “come to an end.”

Anti-counterfeiting legislation being proposed or enacted in other parts of Africa, including Tanzania, Uganda and the East African Community, is also based on advice from IMPACT focused solely on protecting intellectual property (IP) rights, to the detriment of access to affordable medicines, say critics.

At the WHA, the role of IMPACT was supported by delegates from Europe and the USA, who stressed the need to engage all stakeholders to combat the threats presented by counterfeit, falsified and substandard medicines. However Spain, representing the European Union (EU) at the conference session, acknowledged that the only internationally-agreed definition of “counterfeit” - drawn up by the World Trade Organisation (WTO) - can create confusion.

Eduardo Pisani, director general of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), reminded the conference that fake versions of both generic and branded medicines have entered the supply chain in developed as well as developing countries, and added: “all substandard medicines are not counterfeits, however all counterfeits are by their nature, at high risk of being substandard.”

The Assembly concluded with agreement to convene an intergovernmental working group to examine WHO’s role in ensuring availability of good-quality, safe, efficacious and affordable medicine, its relationship with IMPACT and its role in prevention and control of substandard/spurious/falsely-labelled/falsified/counterfeit medical products. Under the agreement, the working group will report back on all these issues at next year’s WHA, and it should restrict itself to public health issues only, with IP or trade issues forming no part of its remit.

At the Assembly, WHO condemned the Dutch customs seizures of Indian-made generic drugs bound for developing nations while in transit through the EU. The Organisation “deplores that this has happened,” said Hendrick Hogerzeil, director of WHO's Essential Medicines Programme, adding that the seizures, which were based on claims of patent violations, were “an improper, unfortunate use of counterfeit legislation.”

This month, India and Brazil launched a WTO dispute procedure concerning the seizures against the EU and the Netherlands. India’s ambassador to the WTO Ujal Singh Bhatia, said the seizures had raised IP issues on drug consignments “where they are absolutely not merited,” and had violated international transit guarantees.

Ambassador Bhatia added that while India had “repeatedly” asked EU and Dutch officials for details of the seizures so it could investigate the claims of counterfeiting, it had “not received details of even one consignment where there was an allegation of sub-standard medicines." At least 19 consignments of Indian-made drugs have been seized while in transit through the EU since the first, of a shipment of generic losartan (Merck & Co’s blood pressure drug Cozaar) bound for Brazil, was impounded by Dutch customs in December 2008, says India.

- As part of the EU/India Free Trade Agreement (FTA) negotiations, the EU is calling on India to brand as “counterfeit” any drug exports which are not in conformity with EU patent laws while they are on European territory, according to the Communist Party of India (Marxist), which calls the request “a crude attempt to justify the illegal seizures that [the EU] has carried out recently.” Along with the rest of the FTA negotiations, the proposals is being discussed in “extreme secrecy,” says the CPM, which is calling on the Indian government to proceed no further on the FTA unless all current proposals and negotiating drafts are debated and discussed in India’s Parliament and with its state governments.